Soft capsules

Abstract

An object of the present invention is to provide soft capsule formulations of active vitamins D, well-suited to practical production with easy discrimination of active ingredient levels, in which stability of the active vitamins D 3 to light and heat is ensured, and which material is highly safe to the human body. According to the present invention, soft capsule formulations of active vitamins D 3 can be obtained-wherein the capsule shell contains a white pigment and yellow iron oxide and/or red iron oxide, or titanium oxide and caramel, or yellow iron oxide.

1. A soft capsule formulation comprising:
 an oily solution of an active vitamin D 3 ; and  
 a soft capsule shell of 200 μm to 600 μm thickness consisting of gelatin, 0.1 to 1.5% by weight of titanium oxide and 0.01 to 1.0% by weight of yellow iron oxide and/or red iron oxide based on the total weight of said soft capsule shell, optionally a dye, optionally another white pigment, optionally a plasticizer, and optionally one or more of ethyl-paraoxybenzoate, propylparaoxybenzoate and potassium sorbate, and  
 encapsulates said oily solution of an active vitamin D 3 .  
 
     
     
       2. A soft capsule formulation according to  claim 1  wherein said dye is present and comprises 0.05 to 1.5% by weight of caramel based on the total weight of said soft capsule shell. 
     
     
       3. The soft capsule formulation of  claim 1  wherein said oily solution comprises at least one base material selected from the group consisting of fatty acid glycerides, propylene glycol fatty acid diesters, triacetin, polyethylene glycols and vegetable oils. 
     
     
       4. The soft capsule formulation of  claim 3 , wherein the base of the oily solution comprises a fatty acid glyceride. 
     
     
       5. The soft capsule formulation of  claim 1  wherein the active vitamin D 3  is selected from 1α-hydroxyvitamin D 3 , 24-hydroxyvitamin D 3 , 25-hydroxyvitamin D 3 , 1α,24-dihydroxyvitamin D 3 , 1α,25-dihydroxyvitamin D 3 , 1α,24,25-trihydroxyvitamin D 3 , 22-oxa-1α,25-dihydroxyvitamin D 2  and 2β-(3-hydroxypropyloxy)-1α,25-dihydroxyvitamin D 3 . 
     
     
       6. The soft capsule formulation of  claim 2  wherein said oily solution comprises at least one base material selected from the group consisting of fatty acid glycerides, propylene glycol fatty acid diesters, triacetin, polyethylene glycols and vegetable oils. 
     
     
       7. The soft capsule formulation of  claim 6 , wherein the base material for the oily solution comprises a fatty acid glyceride. 
     
     
       8. The soft capsule formulation of  claim 2  wherein the active vitamin D 3  is selected from 1α-hydroxyvitamin D 3 , 24-hydroxyvitamin D, 25-hydroxyvitamin D 3 , 1α,24-dihydroxyvitamin D 3 , 1α,25-dihydroxyvitamin D 2 , 1α,24,25-trihydroxyvitamin D 3 , 22-oxa-1α, 25-dihydroxyvitamin D 3  and 2β-(3-hydroxypropyloxy)-1α, 25-dihydroxyvitamin D 3 . 
     
     
       9. A soft capsule formulation comprising;
 an oily solution of an active vitamin D 3 ; and  
 a soft capsule shell of 200 μm to 600 μm thickness consisting essentially of gelatin, 0.1 to 1.5% by weight of a white pigment and 0.01 to 1.0% by weight yellow iron oxide and/or red iron oxide based on the total weight of said soft capsule shell, and encapsulates said oily solution of an active vitamin D 3 ;  
 wherein said white pigment and said iron oxide within said soft capsule shell constitute a homogeneous mixture.  
 
     
     
       10. The soft capsule formulation of  claim 9  wherein said soft capsule shell further comprises 0.05 to 1.5% by weight of caramel. 
     
     
       11. The capsule formulation of  claim 9  or  10  wherein the white pigment is titanium oxide. 
     
     
       12. The soft capsule formulation of  claim 9  wherein said oily solution comprises at least one base material selected from the group consisting of fatty acid glycerides, propylene glycol fatty acid diesters, triacetin, polyethylene glycols and vegetable oils. 
     
     
       13. The soft capsule formulation of  claim 12  wherein the base for the oily solution comprises a fatty acid glyceride. 
     
     
       14. The soft capsule formulation of  claim 9  wherein the active vitamin D 3  is selected from 1α-hydroxyvitamin D 3 , 24-hydroxyvitamin D 3 , 25-hydroxyvitamin D 3 , 1α,24-dihydroxyvitamin D 3 , 1α,25-dihydroxyvitamin D 3 , 1α,24,25-trihydroxyvitamin D 3 , 22-oxa-1α,25-dihydroxyvitamin D 2  and 2β-(3-hydroxypropyloxy)-1α,25-dihydroxyvitamin D 3 .